0021-972X/91/7205-1148$03.00/0 Journal of Clinical Endocrinology and Metabolism Copyright © 1991 by The Endocrine Society
Vol. 72, No. 5 Printed in U.S.A.
Single and Multiple Dose Pharmacokinetics of Methionyl Growth Hormone in Children with Idiopathic Growth Hormone Deficiency* GREGORY L. KEARNS, STEPHEN F. KEMP, AND J. PAUL FRINDIK Departments of Pediatrics (G.L.K., S.F.K., J.P.F.), Pharmaceutics (G.L.K.) and Biochemistry (S.F.K.), University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205-7199; and the Divisions of Pediatric Clinical Pharmacology (G.L.K.) and Endocrinology (S.F.K., J.P.F.), Arkansas Children's Hospital, Little Rock, Arkansas 72202-359
ABSTRACT. The pharmacokinetics (PK) of methionyl GH (metGH) were characterized in 20 newly diagnosed GH-deficient children (19 males; 12.9 ± 3.3 yr old; initial height, 138.8 ± 16.2 cm; weight, 32.1 ± 13.1 kg) after the first dose (FD) of metGH and again after 4-5 weeks of multiple dosing (MD). All subjects received a total metGH dose of 0.3 mg/kg-week by sc administration, but were randomized to receive the drug daily (D; n = 12; dose, 0.043 mg/kg) or three times per week (TIW; n = 8; dose, 0.1 mg/kg). After drug administration, repeated blood samples (n = 14) were obtained over a 10-h period. Concentrations of metGH from each sample were determined using a monoclonal antibody radiometric assay (range of linearity, 0.540.0 ng/ml; coefficient of variation,
Vol. 72, No. 5 Printed in U.S.A.
Single and Multiple Dose Pharmacokinetics of Methionyl Growth Hormone in Children with Idiopathic Growth Hormone Deficiency* GREGORY L. KEARNS, STEPHEN F. KEMP, AND J. PAUL FRINDIK Departments of Pediatrics (G.L.K., S.F.K., J.P.F.), Pharmaceutics (G.L.K.) and Biochemistry (S.F.K.), University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205-7199; and the Divisions of Pediatric Clinical Pharmacology (G.L.K.) and Endocrinology (S.F.K., J.P.F.), Arkansas Children's Hospital, Little Rock, Arkansas 72202-359
ABSTRACT. The pharmacokinetics (PK) of methionyl GH (metGH) were characterized in 20 newly diagnosed GH-deficient children (19 males; 12.9 ± 3.3 yr old; initial height, 138.8 ± 16.2 cm; weight, 32.1 ± 13.1 kg) after the first dose (FD) of metGH and again after 4-5 weeks of multiple dosing (MD). All subjects received a total metGH dose of 0.3 mg/kg-week by sc administration, but were randomized to receive the drug daily (D; n = 12; dose, 0.043 mg/kg) or three times per week (TIW; n = 8; dose, 0.1 mg/kg). After drug administration, repeated blood samples (n = 14) were obtained over a 10-h period. Concentrations of metGH from each sample were determined using a monoclonal antibody radiometric assay (range of linearity, 0.540.0 ng/ml; coefficient of variation,
